Recall Z-0895-2018
Instrumentation Laboratory Co. · initiated August 2, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Codes / lots: Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177.
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.
FDA-determined 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.
Details
- Recall number
- Z-0895-2018
- Initiated
- August 2, 2017
- Posted by FDA
- March 3, 2018
- Terminated
- March 29, 2019
- Product code
- GJS – Test, Time, Prothrombin
- Quantity
- 14,894 kits
- Distribution
- Worldwide Distribution - US Nationwide
- Recalling firm
- Instrumentation Laboratory Co., Bedford, MA