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Terminated

Accumetrics part number 29001 VerifyNow Instrument, printe power supply

FDA Recall Z-0102-06 · Posted 2005-10-28

Recalling FirmAccumetrics Inc
Recall StatusTerminated
Product CodeJOZ
Date Initiated2005-09-13
Date Terminated2007-03-03
Product Quantity11

Reason for Recall

In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply.

Firm Action

Letters and replacement power supplies were sent to consignees by Fedex, 2-day with proof of delivery. End-user customers were instructed to return the affected power supply to Accumetrics, using the provided pre-paid shipping carton. Consignees who do not return the power supply within two weeks of the notification will be contacted by phone to assess compliance with the recall and to determine the status of the product at the site.

Root Cause

Other

Distribution Pattern

CA, FL, IL, LA, NH, NV, NY, OK, WA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992531ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEMAccumetrics, Inc. · 1999-12-20

Official Source

View FDA Recall →

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

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