| Class 2 Device Recall ARCHITECT STAT Myoglobin Calibrators | |
Date Initiated by Firm | March 08, 2022 |
Create Date | April 07, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0891-2022 |
Recall Event ID |
89794 |
510(K)Number | K042924 |
Product Classification |
Calibrator, primary - Product Code JIS
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Product | ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01
The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma. |
Code Information |
UDI: (01)00380740003272(17)220531(10)166000 |
Recalling Firm/ Manufacturer |
Abbott Laboratories 100 Abbott Park Rd Bldg Ap8b Abbott Park IL 60064-3502
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For Additional Information Contact | Suchin Song 224-668-0343 |
Manufacturer Reason for Recall | This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU). |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The firm, Abbott, notified their consignees by "Urgent Medical Device Products Recall" letter on 03/08/2022. The letter explained the issue and requested the use of the affected item be discontinued and destroyed, and the Customer Reply Form be completed and returned via FAX #: 1-800-777-0051 or email PMS@abbott.com. The firm is replacing the product.
If you or any of the health care providers you serve have questions regarding this
information, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). |
Quantity in Commerce | 402 kits |
Distribution | Worldwide Distribution: US (nationwide) and OUS (foreign) including countries of: AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVI, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, GREECE, IRAQ, ITALY, KAZAKHSTAN, LITHUANIA, LUXEMBOURG, MACEDONIA, MOROCCO, PANAMA, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, and TURKEY |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = JIS
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