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Terminated

Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).

FDA Recall Z-1066-2018 · Posted None

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeGJS
Date Initiated2017-10-25
Date Terminated2020-05-12
Product Quantity1636 Kits

Reason for Recall

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Firm Action

Stago sent an Urgent Field Safety Notice letter dated October 25, 2017 to their customers. The letter identified the affected product, problem and actions to be taken: Customers were instructed to: If it is not already done, run a Quality Control test at every change of vial (if you have affected lots of product). Return to company, by fax or email, an acknowledgement form confirming that the recall letter was read by the receiving company. For questions contact the Stago Hotline (1-800-725-0607).

Root Cause

Device Design

Distribution Pattern

Nationally

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K922040NEOPLASTINE CI PLUSAmerican Bioproducts Co. · 1992-06-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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