RecallRadar

FDA Device recall Z-1813-2012

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

On 2012-06-27 the FDA classified a Class III recall of PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 by Tripath Imaging, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1813-2012
ClassificationClass III
Statusterminated
Initiated2012-03-22
Published2012-06-27
Last updated2026-09-13 11:53 UTC
CompanyTripath Imaging
Distributionn/a

Product

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

Reason

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

Identifiers

code_info100917ry, 101105sh, 110107rg

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1813-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.