ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA
FDA Recall Z-1048-04 · Posted 2004-07-20
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Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeGTZ
Date Initiated2004-06-11
Date Terminated2004-10-05
Product Quantity75,368 kits
Reason for Recall
False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control.
Firm Action
A Device Recall Letter was sent to customers that received the affected product lots on 6/11/04 via Federal Express Priority. The accounts were informed of the false positive readings, and were requested to destroy any affected inventory of the recalled lots.
Root Cause
Other
Distribution Pattern
The product was not distributed in the U.S. The product was distributed internationally through Abbott affiliates in Argentina, Korea, the United kingdom, Japan, Singapore, the Dominican Republic, Canada, Hong Kong, Chile and Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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