CLASS III Device recall · Reported 27 Jun 2012 · FDA Enforcement Report

PrepStain Installation Kit (PreCoat) recalled by Tripath Imaging

Tripath Imaging is recalling PrepStain Installation Kit (PreCoat). The recall was initiated on 22 Mar 2012 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codes100917ry, 101105sh, 110107rg
Quantity recalled46,112,784 for all products in Recall Event

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1813-2012
FDA event ID
61737
Recalling firm
Tripath Imaging, Burlington, NC
Classification
Class III
Status
Terminated
Recall initiated
22 Mar 2012
FDA classified
15 Jun 2012
Reported
27 Jun 2012
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Packaging Defects

Timeline

22 Mar 2012Recall initiated by company
15 Jun 2012Classified by FDA+85 days
27 Jun 2012Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

PrepStain Installation Kit (PreCoat), Catalog/Model # 490528

Where it was distributed

Worldwide Distribution.

Questions about this recall

Is PrepStain Installation Kit (PreCoat) recalled?

Yes. Tripath Imaging recalled PrepStain Installation Kit (PreCoat) on 22 Mar 2012. The recall is Class III and its status is Terminated. Recall number Z-1813-2012.

Why was it recalled?

The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

Which lots are affected?

100917ry, 101105sh, 110107rg

Where was it sold?

Worldwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Tripath Imaging

All 9
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIPrepStain PM Kit, T-AG recalled by Tripath ImagingTripath ImagingForeign MaterialNationwide
DeviceCLASS IIPrepStain Upgrade Kit: 3.0.3/1.2 DiTi Cone recalled by Tripath ImagingTripath ImagingForeign MaterialNationwide
DeviceCLASS IIPrepStain Kit: 2 DiTi Cone recalled by Tripath ImagingTripath ImagingForeign MaterialNationwide
DeviceCLASS IIPrepStain Slide Processor recalled by Tripath ImagingTripath ImagingForeign MaterialNationwide
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