Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
FDA Recall Z-1016-2023 · Posted 2023-01-25
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Recalling FirmFuture Diagnostics Solutions B.V.
Recall StatusOpen, Classified
Product CodeCEW
Date Initiated2022-12-06
Product Quantity342 kits
Reason for Recall
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
Firm Action
On 12/06/2022, the firm send a Recall Notice via email to customer informing them that The PTH kit 4K-IPT-00 with lot numbers: M78559, M78560 and M78636 can occasionally give a high duplicate %CV outside the recommended maximum of 15%CV. As a result of the failure in the duplicate CV requires a repeat run it may cause a delay in the patient result turnaround time or in system calibration depending on what samples are run and can lead to a wrong sample result.
Actions to be taken by customers:
-Immediately identify and quarantine the affected lot numbers.
-Further instructions will be provided by the Future Diagnostics.
For questions, send an email to [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution. US states of AZ, CA, CO, LA, OH, PA, and TX; Austria, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Spain, Sweden, and United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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