Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and Cobas c 501clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.
FDA Recall Z-1447-06 · Posted 2006-08-29
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Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCEM
Date Initiated2006-07-21
Date Terminated2006-11-01
Product Quantity137 electrodes
Reason for Recall
Expired product (dated 2006.06) was shipped as replacement for recalled product.
Firm Action
Consignees were notified by phone and sent a recall letter dated 7/21/06 via fax, which instructed them to discontinue use of these lots of product and to discard them.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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