Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
This recall has been terminated (originally issued March 3, 2018).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- August 2, 2017
- Posted
- March 3, 2018
- Terminated
- March 29, 2019
- Recall Number
- Z-0895-2018
- Quantity
- 14,894 kits
- Firm Location
- Bedford, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - US Nationwide
Lot / Code Info
Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177.
Root Cause
Under Investigation by firm
Action Taken
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.