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Class 2 Device Recall Access Ostase QC |
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| Date Initiated by Firm |
May 10, 2011 |
| Date Posted |
June 21, 2011 |
| Recall Status1 |
Terminated 3 on July 11, 2012 |
| Recall Number |
Z-2606-2011 |
| Recall Event ID |
58833 |
| 510(K)Number |
K994277
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| Product Classification |
Single (specified) analyte controls ( assayed and unassayed) - Product Code JJX
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| Product |
Access Immunoassay Systems
Quality Control Kits, Part Number: 37309
The Access Ostase QC is used for monitoring system performance of the Access Ostase assay. |
| Code Information |
Lot Numbers: 911585, 015211, 018855, 020420, 021285, 021640 |
Recalling Firm/
Manufacturer |
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
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Manufacturer Reason
for Recall |
The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials from the affected lots have shown an increased rate of fracturing and may leak the contents in the box during shipment to customers.
Operator injury may occur due to contact with broken glass, exposure to infectious agents, and/or exposure by skin contact to agents that may cause sensitizatio
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FDA Determined
Cause 2 |
Package design/selection |
| Action |
Beckman Coulter sent an PRODUCT CORRECTIVE ACTION (PCA) letter on May 10, 2011 to all affected customers who purchased Access Ostase Calibrators and Access Ostase QC. The letter identified the customers with an explanation of the problem and the potential impact should the problem occur and the action needed to be taken.
Customer were instructed to:
(1) Inspect all Access Ostase Calibrator and QC vials and packaging for signs of failure prior to use, including:
-Cracking, particularly along the bottom of the vial,
-Absence of reagent and/or leaking of contents into the box
(2) Human source material used in the preparation of Access Ostase Calibrator and QC material has been tested and found non-reactive for Hepatitis B (HBV), Hepatitis C (HCV), and Human Immunodeficiency Virus (HIV-1 and HIV-2). No known test method can offer complete assurance that infectious agents are absent. Access Ostase Calibrator and QC vials should be handled in accordance with Good Laboratory Practices, and should be handled as if capable of transmitting infectious disease.
(3) Skin contact with Access Ostase Calibrator and QC material may cause sensitization. Wear suitable gloves when handling vials. If contact with skin occurs, wash immediately with plenty of soap and water.
Customers were told to share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide a copy of the letter to them.
In addition, customers were requested to complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication.
For replacement of defective vials:
(1) In the United States, please contact Client Services at 1-800-526-3821, option 1.
(2) In Canada, please contact Customer Service at 1-800-463-7828.
(3) Outside of the United States and Canada, contac |
| Quantity in Commerce |
702 kits |
| Distribution |
Nationwide in US and worldwide to:
Algeria,
Argentina,
Australia,
Austria,
Belgium,
Canada,
China,
Colombia,
Czech Republic,
France,
Georgia,
Germany,
Greece,
Hong Kong,
Hungary,
India,
Italy,
Japan,
Jordan,
Lebanon,
Liechtenstein,
Mexico,
Morocco,
New Zealand,
Panama,
Reunion,
Romania,
Russian Federation,
Saudi Arabia,
Serbia,
Singapore,
Slovakia,
South Africa,
Spain,
Sweden,
Switzerland,
Taiwan,
Turkey,
United Kingdom |
| Total Product Life Cycle |
TPLC Device Report
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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.
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| 510(K) Database |
510(K)s with Product Code = JJX and Original Applicant = BECKMAN COULTER, INC.
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