Device product
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
Z-1812-2012
Product summary
- Event
- Event 61737
- Status
- Terminated
- Classification
- Class III
- Quantity
- 46,112,784 for all products in Recall Event
- Official record key
device-enforcement:Z-1812-2012
Official wording
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
Code information: 100903ra, 100903rb, 100903rf, 100903rj, 100903rn, 100903rr, 100903rt, 100903rx, 100903sb, 100903sc, 100903sd, 100903se, 100903sf, 100903sl, 100910rd, 100910re, 100910rh, 100910rp, 100910rq, 100910rr, 100917rb, 100917rh, 100917rk, 100917rp, 100917rr, 100917ru, 100917sa, 100917sc, 100917se, 100924ra, 100924ri, 100924rj, 100924rl, 100924rn, 100924rp, 100924rs, 100924rt, 100924ry, 101001ra, 101001rb, 101001rc, 101001rh, 101001rm, 101001rq, 101001ru, 101001rv, 101001rw, 101001ry, 101001rz, 101008ra, 101008rb, 101008rf, 101008rg, 101008rh, 101008ri, 101008rq, 101008rr, 101008rw, 101008rx, 101008sa, 101008sc, 101008sd, 101008se, 101008sf, 101008sg, 101008sh, 101015rh, 101015rk, 101015rr, 101015rw, 101015rx, 101015sd, 101015se, 101015sf, 101015sg, 101022re, 101022rp, 101022rq, 101022sb, 101022si, 101022sk, 101022sl, 101022so, 101022sr, 101022su, 101029ra, 101029rd, 101029re, 101029rh, 101029ri, 101029rx, 101029sc, 101029sd, 101029sf, 101029sk, 101029ss, 101029st, 101105rl, 101105rm, 101105rt, 101105sb, 101105sd, 101105se, 101105sf, 101105sk, 101105sl, 101105so, 101105ss, 101112ra, 101112re, 101112rl, 101112rt, 101112ru, 101112rv, 101112rz, 101112sa, 101112sf, 101112sg, 101112si, 101112sw, 101112sx, 101119ra, 101119ri, 101119rj, 101119rr, 101119ru, 101119rx, 101119ry, 101119rz, 101119sh, 101119sl, 101119so, 101126ra, 101126rg, 101126rl, 101203ra, 101203rb, 101203rc, 101203rd, 101203rh, 101203rj, 101203rp, 101203rr, 101203rs, 101203ru, 101203rw, 101203si, 101203sl, 101203sn, 101203so, 101203sp, 101210rg, 101210rh, 101210rk, 101210rl, 101210ru, 101210rv, 101210rx, 101210sa, 101210sj, 101217ra, 101217rc, 101217rh, 101217rm, 101217rn, 101217rp, 101217rt, 101217rw, 101217rx, 101224rd, 101224re, 101224rg, 101224rk, 101224rl, 101224rt, 101224ru, 101224rv, 101224rw, 101231rc, 101231rd, 101231rg, 101231rh, 101231ri, 101231rj, 101231ro, 101231rp, 110107rh, 110107ri, 110107rk, 110107rp, 110107rq, 110107rr, 110107rz, 110107sb, 110107sc, 110114rf, 110114rg, 110114rv, 110114rw, 110114rx, 110114ry, 110114sj, 110114sk, 110114sm, 110121rd, 110121rn, 110121rq, 110128rd, 110128rp, 110128rq, 110128rx, 110128sb, 110128sc, 110128sg, 110128sl, 110128sn, 110128sp, 110128sq, 110204ra, 110204rd, 110204rg, 110204rj, 110204rq, 110204rv, 110204rx, 110204sd, 110211rb, 110211rd, 110211rg, 110211rj, 110211rn, 110218rw, 110225rk, 110225rl, 100917rc, 101015sb, 101119sg, 101217ro, 110114sc, 110128sk
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Unknown
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