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Terminated

Cannabinoids Intercept Micro Plate EIA 100 plate kit

FDA Recall Z-0481-2009 · Posted 2008-12-18

Recalling FirmOraSure Technologies, Inc.
Recall StatusTerminated
Product CodeLDJ
Date Initiated2008-09-08
Date Terminated2008-12-18
Product Quantity1 kit

Reason for Recall

Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820.

Firm Action

On 9/8/08, the recalling firm telephoned the customer to inform them of the problem. As a follow up to the telephone call, the recalling firm issued a recall letter dated 9/11/08 to the customer.

Root Cause

Other

Distribution Pattern

The product was shipped to one customer in New York.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002375STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118IOraSure Technologies, Inc. · 2001-01-26

Official Source

View FDA Recall →

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

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