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Recall Observatory FDA recall evidence

Device product

Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

Z-2782-2016

July 11, 2016

Class III

Product summary

Firm
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Event
Event 74932
Status
Terminated
Classification
Class III
Quantity
US: 6 kits, Foreign: 50 kits
Official record key
device-enforcement:Z-2782-2016

Official wording

Reason: The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).

Code information: Lot Number 2326060-043, Expiration Date 31 May 2017

Distribution pattern: Distribution to US nationwide including California, and China (Hong Kong).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).