Abbott Laboratories MPG ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Brand
Abbott Laboratories MPG
Lot Codes / Batch Numbers
list 02K43-01, lot number V96128
Products Sold
list 02K43-01, lot number V96128
Abbott Laboratories MPG is recalling ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators rang due to Some of the kits were shipped at the incorrect shipping temperature. They were shipped ambient, but should have been shipped frozen.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some of the kits were shipped at the incorrect shipping temperature. They were shipped ambient, but should have been shipped frozen.
Recommended Action
Per FDA guidance
Abbott telephoned the laboratory end users on 10/17/05, informing them that Abbott discovered that ARCHITECT STAT Myoglobin Calibrators, lot V96128, were shipped to their facilities using the incorrect shipping conditions between August 29th and September 20th 2005. The kits should have been shipped frozen, but were shipped ambient. The error has been corrected. All shipments made after September 21, 2005 have been shipped correctly. Any data generated to date using this kit of calibrators is acceptable, providing that a valid calibration was achieved and product labeling was followed. However, long term use of this kit may result in calibration failures or controls out of range. The accounts were requested to mark the kit(s) of this lot currently in inventory to distinguish them from the replacement kit(s) Abbott will be sending to them. As a precaution, Abbott requested the labs to discontinue use of these kits and destroy them the replacement kits are received.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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Page updated: Jan 10, 2026