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Terminated

IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064

FDA Recall Z-0319-04 · Posted 2004-01-10

Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeLTK
Date Initiated2003-11-25
Date Terminated2004-07-26

Reason for Recall

The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions, 69-6349/R2, refers to an outdated control package insert, 39-1642/R3, instead of the current control package insert 34-1047/R4

Firm Action

Field Correction recall by letter dated 11/25/03 to all customers receiving the affected reagents. The accounts were informed of the incorrect control package insert referenced in the product information letter shipped with each CA 125 product. The letters contained the correct control package insert number, 34-1047/R4, and stated that all CA 125 assay product inserts will be updated shortly to include the revised storage instructions for the CA 125 Calibrators and Controls.

Root Cause

Other

Distribution Pattern

Nationwide and internationally through Abbott subsidiaries in Argentina, Aruba, Australia, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Peru, Hong Kong, India, Jamaica, Japan, Korea, New Zealand, Pakistan, Puerto Rico, Singapore, Taiwan, Thailand, United Kingdom and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964185IMX CA 125Abbott Diagnostics · 1997-11-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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