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U.S. Department of Health and Human Services

Class 3 Device Recall CBC3D Hematology Control, Normal Level Control

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  Class 3 Device Recall CBC3D Hematology Control, Normal Level Control see related information
Date Initiated by Firm November 07, 2022
Date Posted January 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-0999-2023
Recall Event ID 91136
510(K)Number K843962  
Product Classification Mixture, hematology quality control - Product Code JPK
Product R&D CBC-3D Hematology Control:

(1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N;

(2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H;

(3) CBC-3D for Mythic 18 Hematology Control, REF 3D503RX, containing 2 x 2.0 mL each Controls L, N, and H;

(4) CBC-3D For MINDRAY Hematology Control, REF 3D506, containing 2 x 3.0 mL each Controls L, N, and H;

(5) CBC-3D For MINDRAY Hematology Control, REF 3D506US, containing 2 x 3.0 mL each Controls L, N, and H;

(6) CBC-3D TRI PACK Hematology Control, REF 3D507, containing 4 x 2.0 mL each Controls L, N, and H;

(7) CBC-3D TRI PACK Hematology Control, REF 3D508, containing 2 x 2.0 m each Controls L, N, and H;

(8) CBC-3D For ABACUS, REF D3D02 Hematology Control, containing 2 x 3.0 mL each Controls L, N, and H;

(9) CBC-3D For ABACUS Hematology Control, REF D3D04, containing 4 x 3.0 mL each Controls L, N, and H.

Loose tubes labeled CBC-3D Hematology Control in 2.0mL and 3.0mL sizes.

OEM/Own-label distributor labels:

(1) Alere 380 Hemo Control (L-N-H), REF AL35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H; Kit lot #B1122; control lot #B1122N, no UDI

(2) diatron Diacon 3 Hematology Control, Normal Level, 3.0 mL tubes, lot #B1122N

(3) diatron Diacon 3 Hematology Control, REF DN35002-SET, containing 6 x 3.0 mL Control N, kit lot #B1122, control lot #B1122N

(4) diatron Diacon 3 Hematology Control, REF DN35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, Normal control lot #B1122N.

(5) Elite 3 HEM Control Normal, REF HEM00014, containing 6 x 3.0 mL Normal controls, kit lot #B1122, control lot #B1122N;

(6) Erba H3 CON N, REF HEM00034, 3 mL vials, lot #E1122N, exp. 2023-02-10

(7) Horiba Medical Minotrol 16 Whole Blood Hematology Control, Cat. #5300000277, containing 3 x 2.5mL tubes (1 each Control 1, Control 2 (Normal), and Control 3; Cat. #5300000278, containing 6 x 2.5mL tubes (2 each Control 1, Control 2 (Normal), and Control 3; and Cat. #5300000283, containing 12 x 2.5mL tubes (4 each Control 1, Control 2 (Normal), and Control 3; kit lot #MX438, exp. 2023-01-05, Control 2 lot #MX438N.

(8) 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-912-3D; and 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-914-3D.

(9) mindray BC-3D, P/N 040-001423-00.
(10) MINDRAY BC-3D CONTROL, REF BC3D01, containing 1 x 3.0 mL Controls L, N, and H; REF BC3D02, containing 2 x 3.0 mL Controls L, N, and H; and REF BC3D6N, containing 6 x 3.0 mL Control N; kit lot #B1122, control lot #B1122N.

(11) MINDRAY BC-3D CONTROL, REF BC3D02US, containing 2 x 3.0 mL Level L, N, and H, kit lot number B1122, control lot #B1122N.

(12) Nihon Kohden MEK-3D Hematology Control, REF 3DN03, containing MEK-3DN x 3 tubes; REF 3DN06, containing MEK-3DN x 6 tubes; and REF 3DN12, containing MEK-3DN x 12 tubes, kit lot #B22Y, control lot #B22YN.

(13) Nihon Kohden MEK-3DN Normal Hematology Control tubes, 2.0 mL, lot #B22YN.

(14) Orphee MYT-3D, REF MYT301, containing 2 x 2.5 mL Control N; REF MYT302, containing 2 x 2.5 mL each Controls L, N, and H; REF MYT304N, containing 4 x 2.5 mL Control N; REF 306N, containing 6 x 2.5 mL Control N; kit lot #B1122, control lot #B1122N; Myt-3D VET, REF MYT303-VET, containing 1 x 2.5 mL each Control L, N, and H.

(15) Siemens ADVIA 360 Control, REF 11170853, containing 2 x 3.0 mL each Controls Low, Normal & High, kit lot #B0822, GTIN 00630414600833, control lot #B1122N.

(16) URIT HQ-3DIFF, REF 5411000306, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, control lot #B1122N; URIT HQ-3DIFF Hematology Control N tubes, 3.0 mL, lot #B1122N.

(17) Woodley Haematology Control, REF WD1154, containing 6 x 2.0 mL Control N; and REF WD1154A, containing 2 x 2.0 mL each Controls L, N, and H, kit lot number B1122, control lot #B1122N;
Code Information R&D labeled product lot numbers: (Products 1-9): Lot B1122, exp. date 2023-02-05; UDI numbers for the following catalog numbers: 3D501 - UDI 10815762020091; 3D503 - UDI 00815762020117; 3D503RX - UDI 00815762020124; 3D506 - UDI N/A OUS only; 3D506US - UDI 00815762020162; 3D507 - UDI 00815762020179; 3D508 - UDI 00815762020186; D3D02 - UDI 00815762020230; and D3D04 - UDI 00815762020247. OEM/Own-label distributor labeled product lot numbers (Products 1-17) (1) Kit lot #B1122; control lot #B1122N. (2) Lot #B1122N. (3) Kit lot #B1122, control lot #B1122N. (4) Kit lot #B1122, control lot #B1122N. (5) Kit lot #B1122, control lot #B1122N. (6) Lot #E1122N. (7) Kit lot #MX438, Control 2 lot #MX438N. (8) Lot #2022-912-3D and Lot #2022-914-3D. (9) P/N 040-001423-00. (10) Kit lot #B1122, control lot #B1122N. (11) Kit lot number B1122, control lot #B1122N. (12) Kit lot #B22Y, control lot #B22YN. (13) Lot #B22YN. (14) Kit lot #B1122, control lot #B1122N. (15) Kit lot #B0822, GTIN 00630414600833, control lot #B1122N. (16) Kit lot #B1122, control lot #B1122N. (17) Kit lot number B1122, control lot #B1122N;
Recalling Firm/
Manufacturer		 R & D Systems, Inc.
614 Mckinley Pl Ne
Minneapolis MN 55413-2610
For Additional Information Contact Alicia Felthauser
612-656-4501
Manufacturer Reason
for Recall		 For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued letters to their OEM/own-label distributor (OLD) customers on 11/7/2022 via email. The letter informed the OEM/OLD of the issue, requested they inspect the Normal Level control for signs of hemolysis or deterioration, and to discard the tubes if hemolysis or deterioration are noted. They are to sign and return the Acknowledgement and Receipt form via email by 12/2/2022. The letter informs the OEM/OLD that a new lot of CBC-3D Normal Level Hematology Control will be available 1/9/2023. The letter did not request them to notify their customers. Updated OEM/OLD letters were issued 11/14/2022 which changed the acknowledgement form to indicate the OEM/OLD has initiated a recall for the product and is notifying their customers. The consignee letters for the recalling firm's customers were issued 11/10/2022 via email. Distributor consignees who have the product drop-shipped to their end users are notifying their own end users. The letter explains the issue, and instructs them to inspect the Normal Level control for signs of hemolysis or deterioration. If signs of hemolysis or deterioration were noted, the tube is to be discarded. An Acknowledgement and Receipt form was enclosed for return to the firm by 11/22/2022 via email. The letter informs the consignee that a new lot of CBC-3D Normal Level Hematology Control will be available 1/9/2023. Also attached to the letter is a Generic Customer Letter to be sent to the distributor's end user customer along with a Customer Medical Device Important Product Notice Return Form. The Generic Customer Letter is to be sent with a cover letter from the distributor partner. On 11/21/2022, the recalling firm issued an email to one customer to notify them that catalog number 3D502 was not impacted by the recall, as it had been listed on the notification issued on 11/10/2022.
Quantity in Commerce 8,259 kits, 28,136 labeled loose tubes, and 15,926 unlabeled loose tubes
Distribution Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IA, KY, LA, MA, MO, NC, NJ, NY, OH, TX and Puerto Rico. The countries of Brazil, China, Costa Rica, Czech Republic, France, Germany, Great Britain, Honduras, Hungary, Indonesia, Israel, Japan, Kuwait, Mexico, Netherlands, Nicaragua, Panama, Peru, Poland, Romania, San Salvador, South Africa, South Korea, Switzerland, Thailand, Turkey, Vietnam,.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JPK and Original Applicant = R & D SYSTEMS, INC.
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