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Terminated

Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000

FDA Recall Z-1419-2018 · Posted None

Recalling FirmOraSure Technologies, Inc.
Recall StatusTerminated
Product CodeDIO
Date Initiated2017-12-20
Date Terminated2020-04-02
Product Quantity10

Reason for Recall

The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.

Firm Action

The email to the firm's consignees states the controls will be replaced.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed to 2 consignees in KS.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982061STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)OraSure Technologies, Inc. · 1998-08-25

Official Source

View FDA Recall →

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

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