Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
FDA Recall Z-0895-2018 · Posted 2018-03-03
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Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeGJS
Date Initiated2017-08-02
Date Terminated2019-03-29
Product Quantity14,894 kits
Reason for Recall
Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.
Firm Action
On August 2, 2017, Instrumentation Laboratory sent an Urgent Medical Device Removal letters dated August 2, 2017 to their customers. On October 5, 2017 Instrumentation Laboratory expanded their recall adding 3 additional lots to a second Urgent Medical Device Removal letter. On February 26, 2018, Instrumentation Laboratory expanded their recall a 3rd time to include 1 additional lot to a third Urgent Medical Device Removal letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a Mandatory Tracking Response form. For questions contact your Customer Service Representative at 1-800-955-9525, option #1.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - US Nationwide
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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