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Terminated

MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

FDA Recall Z-1797-2018 · Posted None

Recalling FirmDiagnostic Hybrids, Inc.
Recall StatusTerminated
Product CodeCIN
Date Initiated2016-07-14
Date Terminated2020-08-28
Product Quantity1004

Reason for Recall

There is a possibility of low volume and/or leaking standard bottles.

Firm Action

Customers were contacted via telephone and a letter dated 7/14/16. The letter instructed customers to review their inventory for the specified lot number, check for any low-volume or leaking standards, and contact the recalling firm if necessary.

Root Cause

Process control

Distribution Pattern

The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Switzerland, and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981373ALKPHASE-B ASSAY KITMetra Biosystems, Inc. · 1998-05-27

Official Source

View FDA Recall →

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

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