Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent Assay (ELISA)
FDA device recall Z-2047-2011 · posted 2011-04-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values for patient serum samples due to a shift in the assigned calibrator values. Beckman Coulter recommends that patient results generated with the affected lot be evaluated in the context of other diagnostic tests and the clinical presentatio
- Action taken
- The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" Letter dated August 03, 2009 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: Action/Resolution: Discontinue use and discard remaining product with lot number 890291 of Active Prolactin reagents. Contact Beckman Coulter at 1-800-231-7970 for replacement product. Newer lots (lot number 991210 or higher) of the product have been realibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, they were told to contact Technical support at the phone number listed below. Consignees were asked to share this information with their laboratory staff and retain this letter for their Quality System documentation and asked to complete and return the enclosed response form within 10 days via fax to: 786-639-4000 so that Beckman can be assured that they received the notification. If you have any other questions regarding this notification, please contact DSL Technical Support Center at 1-800-231-7970 in the United States and Canada , or contact their local Beckman Coulter Representative.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- CFT
- Quantity affected
- 30 Kits
- Distribution
- Nationwide distribution: USA including states of: FL, GA and NC.
- Date initiated
- 2009-08-03
- Date posted
- 2011-04-20
- Date terminated
- 2012-04-27
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (K960561) | Diagnostic Systems Laboratories, Inc. | 1996-04-26 |