ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of Ig

FDA device recall Z-2413-2011 · posted 2011-06-06 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results.

Action taken

Abbott Laboratories issued a Product Recall letters dated April 20, 2011 to all affected customers that received ARCHITECT HAVAB-M reagent, lot 93794HN00. The letters informed the accounts of the increased grayzone and/or reactive results and were instructed to discontinue use of the lot and destroy any remaining inventory of the lot according to laboratory procedures. If the account did not have an alternate lot of reagent, they were told to continue using the recalled lot until their lab receives the replacement lot, and to perform supplemental testing with another HAVAB-M method to confirm the results for all specimens that are grayzone or reactive. The accounts were also requested to complete and fax back to Abbott the enclosed customer reply sheet, acknowledging the receipt and understanding of the recall. For further questions regarding this please contact Abbott at 1-877-422-688

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LOL

Quantity affected

788 kits

Distribution

Nationwide Distribution including Puerto Rico

Date initiated

2011-04-20

Date posted

2011-06-06

Date terminated

2012-02-10

Location

Abbott Park, IL

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