Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT PART A Model/List Number 01H77-01 (4x3.8L), 01H75-01A
FDA device recall Z-0632-03 · posted 2003-03-12 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Product may elicit fluorescent signal interference due to bacterial contamination.
- Action taken
- On 1/31/03, the firm initiated the recall and their notification was via letters requesting 'locate and discard' affected device.
- Root cause
- Other
- Status
- Terminated
- Product code
- JPK
- Quantity affected
- 8826 units
- Distribution
- Product was released for distribution to 428 consignees in U.S. and 17 foreign consignees. The U.S. States include: AL, AZ, CA, CO, FL, GA, IA, MN, MO, NY, NC, SC, TN, TX and UT; and foreign accounts
- Date initiated
- 2003-01-10
- Date posted
- 2003-03-12
- Date terminated
- 2003-09-17
- Location
- Santa Clara, CA
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