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Terminated

Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892

FDA Recall Z-0361-2007 · Posted 2007-01-23

Recalling FirmDiagnostic Chemicals, Ltd.
Recall StatusTerminated
Product CodeDKJ
Date Initiated2006-12-05
Date Terminated2016-01-27
Product Quantity55 kits shipped to one customer

Reason for Recall

Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end users, DCL cannot be certain which instruments the end users employ in their laboratories

Firm Action

For product shipped by DCL to one customer notification letter dated 12/5/06 sent out to customer to return/discard product. Replacement will be sent to customer. For product shipped to DCL (USA) warehouse notification sent to discard kits remaining in stock. For product remaining at DCL Canada in-house notification sent out to discard in-house kits.

Root Cause

Other

Distribution Pattern

PA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042329SALICYLATE-SL ASSAYDiagnostic Chemicals , Ltd. · 2004-12-27

Official Source

View FDA Recall →

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

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