FDA Device recall Z-1815-2012
PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syring…
- FDA Device
- Class III
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class III recall of PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syring… 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-1815-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-03-22 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tripath Imaging |
| Distribution | n/a |
Product
PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
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_info | This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the actual prod…This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the actual product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240), which are: 100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n, 101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c, 101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b, 110128i, 110203i, 110210r |
|---|
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-1815-2012%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.