ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 10

FDA device recall Z-1904-2012 · posted 2012-06-29 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.

Action taken

The firm, Abbott Laboratories, sent a "Product Recall Immediate Action Required" letter dated May 30, 2012 to all Architect CA 19-9XR customers who received the affected reagent lots. The customers were directed to immediately discontinue use and destroy any remaining inventory of the lots listed; to review the patient results obtained with the affected lots with the treating physician or heath care provider to ensure they are aware of the potential analytical issue and can determine whether re-evaluation of the patient is necessary; to forward a copy of the letter to any laboratory to whom they may have forwarded the reagent; and to retain a copy of the letter for their records and to complete and return the Customer Reply Form via fax to: 1-800-777-0051 or e-mail: QAGCO@abbott.com. For questions were call your local Customer Service representative or call the field action coordinator at 847-938-1923.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NIG

Quantity affected

316 kits - USA, 8,356 kits ROW

Distribution

Worldwide Distribution - US (nationwide) the states of: Alabama, Arkansas, Arizona, California, Florida, Iowa, Indiana, Louisiana, Michigan, Minnesota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pe

Date initiated

2012-05-30

Date posted

2012-06-29

Date terminated

2016-12-23

Location

Abbott Park, IL

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