RealTime 04J71-95

• FDA 510(k) K092705 decided 28 May 2010 Active
• FDA GUDID UDI-DI 00884999006584 listed 1 Sep 2016 Listed

• • Terminated Z-0463-2015 FDA Class II ·initiated 23 Oct 2014

  Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Software error) to be generated when the Available Reagent Packs screen is selected.

• • Terminated Z-2169-2014 FDA Class II ·initiated 19 Jun 2014

  Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held securely in the 1 mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it.

• • Terminated Z-0948-2015 FDA Class II ·initiated 23 Nov 2013

  The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.

• • Terminated Z-0634-2013 FDA Class II ·initiated 4 Dec 2012

  An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved.

• • Terminated Z-2013-2012 FDA Class II ·initiated 31 Jan 2012 ·on shared 510(k) K092705

  In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format. The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories. It is comprised of the Ab

• • Terminated Z-0365-2012 FDA Unclassified (pre-2012) ·initiated 11 Oct 2011

  Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.

• • Terminated Z-0048-2012 FDA Unclassified (pre-2012) ·initiated 8 Sep 2011 ·on shared 510(k) K092705

  The Abbott m2000rt System software has software bug which can affect customers who manually enter a Test Order onto the m2000rt and sorts a column on the calibration or control grids of the Test Order screen by double clicking the column header. This causes a mismatch between specific concentration values and the designated calibrators and controls in the final results, which could cause an inval

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 28 May 2010 Cleared FDA 510(k) K092705
2. 8 Sep 2011 Recall initiated FDA recalls Z-0048-2012
3. 11 Oct 2011 Recall initiated FDA recalls Z-0365-2012
4. 31 Jan 2012 Recall initiated FDA recalls Z-2013-2012
5. 4 Dec 2012 Recall initiated FDA recalls Z-0634-2013
6. 23 Nov 2013 Recall initiated FDA recalls Z-0948-2015
7. 19 Jun 2014 Recall initiated FDA recalls Z-2169-2014
8. 23 Oct 2014 Recall initiated FDA recalls Z-0463-2015
9. 1 Sep 2016 Listed FDA GUDID 00884999006584

Trade name

RealTime

Generic name

Test tube/reservoir cap

Model / Ref / Catalog

04J71-95

Primary DI / UDI-DI

00884999006584

510(k) Number

K092705 ↗

FDA product code

JJH

GMDN term

Test tube/reservoir cap

Device class

Class I

Regulation number

862.2310

GUDID distribution status

In Commercial Distribution

Category: Test tube/reservoir cap

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