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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT STAT Myoglobin Calibrators

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  Class 2 Device Recall ARCHITECT STAT Myoglobin Calibrators see related information
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
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
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
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 = JIS and Original Applicant = FISHER DIAGNOSTICS
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