Z-1784-2013Class II

HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the...

Name: Z-1784-2013 HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the...
Creator: Instrumentation Laboratory Co.
Published: 2013-04-09
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2013-04-09 / Terminated / root cause: manufacturing process

FDA source

Instrumentation Laboratory Co. began a recall of HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring... on 2013-04-09. FDA classified it as Class II and gives the reason as "Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1784-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-09
Posted: 2013-07-22
Terminated: 2015-05-06
Recalling firm: Instrumentation Laboratory Co.
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.
Product code: GJS Test, Time, Prothrombin
Reason for recall: Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 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, CA, OR, WA, AK, RI, VT and the countries of: Angola, Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Bulgaria, Canada, Caribbean, Chile, Colombia, Costa Rica, Czech, Denmark, Dubai, Ecuador, Egypt, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hungary, India, Indonesia, Iran, Israel, Italy, Jamaica, Jordan, Korea, Kosovo, Kuwait, Lebanon, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Turkey, Ukraine, Uruguay, Vietnam, and Japan.
Product codes and lots: Part Number applies to all: 0020002950 - all product lots. Lot Numbers: 1) N0716706 Exp. Date 5/31/2013, 2) N0817321 Exp. Date 5/31/2013, 3) E0917396 Exp. Date 9/30/2013, 4)) N0917378 Exp. Date 9/30/2013, 5) N1118029 Exp. Date 10/31/2013, 6) N0128669 Exp. Date 1/31/2014, 7) N0329291 Exp. Date 2/28/2014, 8) N0429596 Exp. Date 3/31/2014, 9) N0520056 Exp. Date 5/31/2014,10) E0720822 Exp. Date 7/31/2014, 11) N0821174 Exp. Date 8/31/2014, 12) N091388 Exp. Date 9/30/2014, 13) N0921522 Exp. Date 9/30/2014, 14) N0132676 Exp. Date 1/31/2015 and 15) N1222567 Exp. Date 1/31/2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1784-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1784-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22

Product code GJS

K070005Class IIHemosil Recombiplastin 2GInstrumentation Laboratory CO / cleared 2007-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)