Recall Z-1784-2013— Instrumentation Laboratory Co.
Class II · Terminated
Class II FDA medical device recall by Instrumentation Laboratory Co., initiated 2013-04-09, terminated 2015-05-06. It names one FDA 510(k) clearance: K070005. Product: HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.. Reason: Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification..
- Recalling firm
- Instrumentation Laboratory Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-09
- Terminated
- 2015-05-06
- Firm location
- Bedford, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
Reason for recall
Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.