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Terminated

AIA-PACK TPOAb CONTROL SET

FDA Recall Z-2168-2017 · Posted 2017-05-15

Recalling FirmTosoh Bioscience, Inc.
Recall StatusTerminated
Product CodeJZO
Date Initiated2017-02-08
Date Terminated2019-02-08
Product Quantity15 boxes

Reason for Recall

The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.

Firm Action

On 3/3/2017 the firm sent recall notificaion letters to their customers.

Root Cause

Labeling mix-ups

Distribution Pattern

Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981521AIA-PACK TPOAB ASSAYTosoh Medics, Inc. · 1998-10-08

Official Source

View FDA Recall →

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

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