API® CORYNE ZYM BX2
Received Dec 11, 2015
Report 3002769706-2015-00167 · MDR key 5290185
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
ON (B)(6) 2015 A CUSTOMER REPORTED A NON-REACTIVE RESULT WITH PRODUCT AP CORYNE ZYM BX2. THE CUSTOMER STATED WHEN RUNNING QC TESTS ALL THE RESULTS WERE NEGATIVE WITH NO POSITIVE RESULTS. NO PATIENT RESULTS WERE AFFECTED, NO LATE RESULTS REPORTED.
Additional Manufacturer Narrative
BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. INVESTIGATIONAL TESTING INCLUDED PERFORMANCE CHECKS OF THE TWO (2) INCRIMINATED AMPULES FOR API® ZYMB X2 USING FIVE (5) BATCHES FROM RETAINED STOCK. - LOT 1003787970 - LOT 1003772470 - LOT 1003772410 - LOT 1003790030 - LOT 1003547280. NON-CONFORMITY WAS OBSERVED IN THE TWO AMPULES OF INTEREST FOR ALL FIVE (5) BATCHES (10 AMPULES TOTAL). SALE OF REFERENCE 70493 (API® ZYMB X2) WAS DISCONTINUED VIA PRODUCT STOP SHIPMENT PSS #(B)(4). FIELD SAFETY CORRECTIVE ACTION (FCSA-2752) AND URGENT PRODUCT CORRECTION NOTICE (CUSTOMER LETTER) WAS ISSUED TO THE FIELD DECEMBER 22, 2015. CAPA #(B)(4) WAS INITIATED TO DEFINE THE CORRECTIVE AND PREVENTATIVE ACTION PLAN.
Remedial action
- Recall