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U.S. Department of Health and Human Services

Class 2 Device Recall ABX Pentra Calcium AS CP

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  Class 2 Device Recall ABX Pentra Calcium AS CP see related information
Date Initiated by Firm October 22, 2021
Create Date May 26, 2022
Recall Status1 Terminated 3 on January 04, 2023
Recall Number Z-1140-2022
Recall Event ID 90126
510(K)Number K060205  
Product Classification Cresolphthalein complexone, calcium - Product Code CIC
Product ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
Code Information Model Number: HII1220001954; Lot Numbers: 215907578 (Expiration Date 09/30/2022), 215907729 (Expiration Date 02/28/2023); Manufacturer Number: A11A01954
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		 Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.
FDA Determined
Cause 2		 Process control
Action Medline contacted affected consignee via telephone on 10/22/2021 and confirmed that the product had been destroyed.
Quantity in Commerce 6 boxes
Distribution US Distribution to North Carolina.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CIC and Original Applicant = HORIBA ABX
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