ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to

FDA device recall Z-0400-06 · posted 2006-01-18 · Terminated

Recall details

Recalling firm

Abbott Laboratories MPG

Reason for recall

Some of the kits were shipped at the incorrect shipping temperature. They were shipped ambient, but should have been shipped frozen.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

DDR

Quantity affected

11 kits

Distribution

Texas, Washington, Montana, Pennsylvania and Kentucky, and internationally to Korea

Date initiated

2005-10-17

Date posted

2006-01-18

Date terminated

2006-05-25

Location

Abbott Park, IL

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