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
This recall has been terminated (originally issued March 26, 2003).
- Company
- Abbott Laboratories Hpd/Add
- Recall Initiated
- March 4, 2003
- Posted
- March 26, 2003
- Terminated
- September 15, 2004
- Recall Number
- Z-0680-03
- Quantity
- 792 packs
- Firm Location
- Abbott Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
Distribution
Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.
Lot / Code Info
list 9C08-01, lot 88127M100
Root Cause
Other
Action Taken
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.
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