HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic c
FDA device recall Z-1784-2013 · posted 2013-07-22 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- Reason for recall
- Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.
- Action taken
- Between April 9, 2013 and April 11, 2013, Instrumentation Laboratory distributed "Important Product Correction" notification letters to their U.S. and foreign customers informing them that the on-board instrument stability claim has been reduced to 3 days for all current and future product lots of HemosIL RecombiPlasTin 2G. A second notification to non-respondents was initiated and completed on May 7, 2013. Technical questions were referred to 1-800-678-0710, Option # 2.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- Kits per product:1)11080, 2)11603, 3)11487, 4)11483, 5)11290, 6)11562, 7)11535, 8)11577, 9)11505, 10)11708,11)11579,12)11580, 13&14) not distributed
- Distribution
- Worldwide Distribution- US (nationwide) including states of: MA, ME, CT, NJ, NY, PA, MD, VA, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, ID, AZ,
- Date initiated
- 2013-04-09
- Date posted
- 2013-07-22
- Date terminated
- 2015-05-06
- Location
- Bedford, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOSIL RECOMBIPLASTIN 2G (K070005) | Instrumentation Laboratory CO | 2007-08-15 |