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Terminated

Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum.

FDA Recall Z-1327-2009 · Posted 2009-05-13

Recalling FirmDiagnostic Chemicals, Ltd.
Recall StatusTerminated
Product CodeJMO
Date Initiated2008-03-14
Date Terminated2012-05-16
Product Quantity153 kits

Reason for Recall

Precipitate in product may cause elevated background absorbance interference.

Firm Action

Genzyme Diagnostics P.E.I. Inc. notified the 1 account by a Removal Notification letter on 3/14/08 requesting that they stop using and discard any remaining stock. The customer is to request replacement through their normal channels. Questions or concerns should be directed to Penny White of Genzyme.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961587IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25Diagnostic Chemicals , Ltd. · 1996-08-27

Official Source

View FDA Recall →

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

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