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Terminated

CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL; Abbott Laboratories, Abbott Park, IL 60064

FDA Recall Z-0680-03 · Posted 2003-03-26

Recalling FirmAbbott Laboratories HPD/ADD
Recall StatusTerminated
Product CodeMOI
Date Initiated2003-03-04
Date Terminated2004-09-15
Product Quantity792 packs

Reason for Recall

The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.

Firm Action

Recalled by letter dated 3/4/03. The accounts were informed of the depressed values for the CA 15-3 High Control and for patient specimens, and were requested to discontinue use and destroy any of the three affected lots found in inventory.

Root Cause

Other

Distribution Pattern

Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964407IMX CA 15-3Abbott Laboratories · 1997-11-10K963926AXSYM CA 15-3Abbott Laboratories · 1997-09-15

Official Source

View FDA Recall →

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

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