Recall Z-0102-06 ยท JOZ System, Automated Platelet Aggregation
Accumetrics Inc
Accumetrics part number 29001 VerifyNow Instrument, printe power supply
| Date | Oct 28, 2005 (initiated Sep 13, 2005) |
| Status | Terminated |
| Reason | In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply. |
| Root cause | Other |
| 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. |
| Quantity | 11 |
| Distribution | CA, FL, IL, LA, NH, NV, NY, OK, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992531 | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM Accumetrics, Inc., Dec 20, 1999 |